Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.

The medical device industry faces the challenge of delivering safe and cost-effective products on time, every time. By Ken Peterson

The end of 2013 saw numerous drugs change clinical phase or receive approval and launch, creating an exciting landscape for drugs to watch in 2014.  Whether it’s a new HIV drug gaining approval or the advancement of a rheumatoid arthritis therapy from phase II to phase III trials, The Ones to Watch, a quarterly report from Thomson Reuters, keeps a finger on the pulse of the most promising drugs by mining strategic data from Cortellis^TM Competitive Intelligence.

Using these insights, Thomson Reuters analysts found that orphan drugs feature prominently in the market, with the recent launch of two drugs for orphan cancer indications: Gazyva^TM and Valchlor^TM, and important phase transitions for several others. In the US there have been nearly 250 labeled indications relating to orphan drug designations approved since the enactment of the Orphan Drug Act in 1983. Cortellis Competitive Intelligence describes over 800 drugs that have received at least one orphan designation.

In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature controlled – collecting, communicating and analyzing temperature and logistics data is critical to success.